NANOBIOTIX completes patient inclusion for Phase II/III trial of NBTXR3 in soft tissue sarcoma
October 23 2017 - 2:01AM
Nanobiotix completes patient inclusion
for Phase II/III trial of NBTXR3 in soft tissue
sarcoma
Paris, France and Cambridge, Massachusetts,
USA, October 23, 2017 - NANOBIOTIX NANOBIOTIX(Euronext:
NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine
company pioneering new approaches to the treatment of cancer, today
announced that it has completed patient inclusion for the Phase
II/III trial (Act.In.Sarc) of its lead product candidate, NBTXR3,
in soft tissue sarcoma. The last patients are expected to start
their treatment in two to three weeks.
Elsa Borghi, Nanobiotix's Chief Medical Officer
commented: "We are pleased to have reached this important milestone
in Nanobiotix's soft tissue sarcoma study, and we look forward to
reporting our first data next year."
The pivotal international Phase II/III study in
soft tissue sarcoma was launched in Europe and Asia in October 2014
and aims to evaluate the safety and the efficacy of NBTXR3, a
first-in-class radio-enhancer that could potentially target most
solid tumors. The Phase II/III study is a prospective, randomized,
multi-center, open label and active controlled two-arm study of 156
patients with locally advanced soft tissue sarcoma.
The trial's primary endpoint is the complete
pathological response rate. The secondary endpoints are the
objective response rate (ORR) by imaging (MRI); the evaluation of
the safety profile in terms of clinical and laboratory adverse
events; the tumor volume changes; the resection margins and the
limb amputation rate. Furthermore, an exploratory analysis of the
progression free survival is planned once the follow-up period has
been completed for all treated patients.
Nanobiotix expects to present the results of its
Phase II/III trial in soft tissue sarcoma in the first half of
2018.
For more information about the study: Clinical
trial.gov and http://www.actinsarc.com/.
***
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to providing a new, more efficient
treatment for cancer patients.
NanoXray products are compatible with current
radiotherapy treatments and are meant to treat potentially a wide
variety of solid tumors including soft tissue sarcoma, head and
neck cancers, liver cancers, prostate cancer, breast cancer,
glioblastoma, etc., via multiple routes of administration.
NBTXR3 is being evaluated in: soft tissue
sarcoma (STS), head and neck cancers, prostate cancer, and liver
cancers (primary and metastases). Additionally, head and neck
cancer and rectal cancer trials led by Nanobiotix's Taiwanese
partner, PharmaEngine, are underway in the Asia Pacific region. The
Company filed in August 2016 for market approval (CE Marking) in
Europe for its lead product NBTXR3.
In 2016 the Company started a new preclinical
research program in Immuno-oncology with its lead product NBTXR3,
which could have the potential to bring a new dimension to cancer
immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company's Headquarters is based in Paris,
France, with a U.S. affiliate in Cambridge, MA.
Contact
Nanobiotix |
Sarah GaubertDirector, Communications & Public
Affairs+33 (0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël Kurdi Director, Investor
Relations +1 (646) 241-4400 noel.kurdi@nanobiotix.com /
investors@nanobiotix.com |
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States -
RooneyPartners Marion Janic +1 (212)
223-4017mjanic@rooneyco.com |
|
Disclaimer
This press release contains certain
forward-looking statements concerning Nanobiotix and its business.
Such forward-looking statements are based on assumptions that
Nanobiotix considers to be reasonable. However, there can be no
assurance that the estimates contained in such forward-looking
statements will be verified, which estimates are subject to
numerous risks including the risks set forth in the reference
document of Nanobiotix filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) under number D.17-0470
on April 28, 2017 (a copy of which is available on
www.nanobiotix.com) and to the development of economic conditions,
financial markets and the markets in which Nanobiotix operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Nanobiotix or not currently
considered material by Nanobiotix. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of Nanobiotix to be materially
different from such forward-looking statements.
This press release and the information that it
contains do not constitute an offer to sell or subscribe for, or a
solicitation of an offer to purchase or subscribe for, Nanobiotix
shares in any country. At the moment NBTXR3 does not bear a CE mark
and is not permitted to be placed on the market or put into service
until NBTXR3 has obtained a CE mark.
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